Left bundle branch area pacing versus conventional right‑ventricular pacing after TAVI for atrioventricular block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls patients who develop atrioventricular block within three months after transcatheter aortic valve implantation and have preserved left ventricular ejection fraction. Participants meeting guideline indications for pacemaker implantation will receive either left bundle branch area pacing or conventional right‑ventricular pacemaker implantation at participating centers. Clinical and echocardiographic outcomes such as changes in LVEF, heart failure hospitalizations, and mortality will be compared during follow‑up. The intent is to see if physiological conduction via left bundle branch area pacing reduces pacing‑induced dyssynchrony and downstream complications compared with standard pacing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
* Preserved left ventricular ejection fraction (LVEF ≥ 50%)
* Indications for pacemaker implantation according to guidelines, including :
* Third-degree atrioventricular (AV) block
* Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
* Alternating left and right bundle branch block
* HV interval ≥ 70 ms during electrophysiological study
* Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI
* Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation
* Signed informed consent
* Patient affiliated with the national health insurance system

Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \< 50% before TAVI
* Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
* Previously implanted pacemaker
* Patients under legal guardianship, curatorship, or judicial protection
* Participation in another interventional therapeutic clinical trial

Where it's running

• Brest University Hospital
  Brest, Finistère, France Recruiting
• Rennes University Hospital
  Rennes, Ille-et-Vilaine, France Recruiting
• Tours University Hospital
  Tours, Indre-et-Loire, France Recruiting
• Nantes University Hospital
  Nantes, Loire-Atlantique, France Recruiting
• Rouen University Hospital
  Rouen, Seine-Maritime, France Recruiting
• Poitiers University Hospital
  Poitiers, Vienne, France Recruiting

Study contacts

• Study coordinator: Research and Innovation Departement of Nantes UH
• Email: bp-prom-regl@chu-nantes.fr
• Phone: +33253482810

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.